Regulatory requirements, multi-site coordination, institutional needs—there are many complexities that can slow down research. With our unparalleled regulatory expertise and experience, WIRB can manage these complexities and ensure your research gets a thorough review quickly.

Expertise

Accredited by AAHRPP since 2003 and with more than 30 Certified IRB Professionals (CIPs) on staff, we have decades of expertise and deep regulatory insight. Our IRB review services span the full spectrum of human research, including tissue, DNA, clinical, device, and behavioral studies. Serving sponsors, contract research organizations (CROs), institutions, and private investigators as a local, central, or multi-center IRB, we deliver expert review of academic, government, and industry- sponsored research around the globe.

WIRB has a select panel dedicated to reviewing Environmental Protection Agency, Department of Defense, Department of Justice, Department of Education, and International Traffic in Arms research. We also review research performed on special populations, including children, pregnant women, and prisoners.

Each year, WIRB performs independent reviews of more than 2,500 new clinical trials while also monitoring approximately 6,000 ongoing trials. This equates to our reviewing nearly 8,000 investigators conducting new research each year, and monitoring nearly 20,000 ongoing investigator sites. WIRB's experience reviewing such a vast range of protocols—of every size and level of complexity—is proof we have the capacity, expertise, and efficiency you require.

Seven review panels

With 7 individual panels performing Board reviews, WIRB has the capacity to review the full spectrum of human subject research. Our panel members include physicians, lawyers, clergy, and community members who undergo rigorous and ongoing regulatory training on human subject safety. And, because our panel members are volunteers who are independent of WIRB, their reviews are conducted without bias. More than 45 individuals have served on WIRB panels for over a decade, a testament to their commitment to and expertise in human subject protection.

Client portal

WIRB Connexus, WIRB's client portal, enables you to securely submit and track research at any time throughout the course of your study. Our web portal and accompanying guidelines outline the submission process for your protocol with step-by-step instructions for submitting and tracking your review. Smart forms help ensure your submission is complete, avoiding time-consuming delays. Using WIRB Connexus, you can also track where your study is in the review process and immediately address any outstanding issues.

Quality services

Throughout the review process, WIRB provides proactive and personalized communications to keep you informed. We also strive to keep you updated on human subject protection regulations, processes, and best practices.

View WIRB's Compliance Statement, and learn more about WIRB's registration with OHRP/FDA, AAHRPP accreditation, and electronic signatures' compliance with 21 CFR Part 11.

Getting it done right, and getting it done quickly, requires the kind of experience and capacity that WIRB offers. Our staff is deeply committed to streamlining your review process, while ensuring that your study adheres to the highest standards for protecting human research participants and complying with regulations. Throughout your review, we strive for efficiency that balances speed and quality—critical to helping you achieve both your short-term and long-term goals.

WIRB's IRB services for sponsors and CROs include:

Local IRB

WIRB provides review services for more than 400 institutions and their affiliates (academic centers, hospitals, networks, and in-house biotech research), as well as individual investigators. Our long-standing institutional relationships give us deep knowledge of unique investigator requirements and established consent language for different institutions, enabling us to streamline reviews. The result is faster review turnaround and site start-up.

Central IRB

WIRB has served as a central IRB for individual investigators since our inception. Our relationships and review histories with investigators around the world provide us with more insight into human protection regulations and regulatory nuances than any other independent IRB.

Multi-center studies

With experience reviewing multi-center studies involving up to several thousand investigators, WIRB has implemented time-saving and cost-saving review procedures and a dedicated account manager to accelerate the multi-center review process. We help sponsors and CROs more efficiently plan, submit, and implement a compliant study. We review your initial protocol, changes in research, and associated documents up-front identifying issues to be addressed prior to site submissions. We also develop a consent form template for site use. And, to help you rapidly onboard new sites, the Board meets three times a week to review new sites joining an already Board-approved study.

A WIRB account manager is assigned to your protocol to facilitate research review and oversight, serving as a single point of contact for questions and communications, helping manage document flow, and coordinating communications between all investigators involved. Learn more about multi-center studies.

Clinical Pharmacology Unit review

WIRB provides streamlined reviews for dedicated clinical pharmacology units addressing healthy and diseased populations, including Phase 1, bioequivalence/bioavailability, diabetes, oncology, and renal disease research. We respond quickly to submissions, helping advance your research through local and international regulatory procedures anywhere in the world. Learn more about our CPU Services.

Global IRB services

With review experience in more than 70 countries, WIRB can help you meet all the logistical, cultural, and regulatory challenges of international research. If you are planning an international study, WIRB's established international network and deep knowledge of global regulations and cultural sensitivities can help pave the way for a compliant review around the globe. Learn more about our international and Canadian IRB services.

Education and consulting

WIRB's staff of experts and educators offers a wide array of education, consulting, and staffing services for investigators, local IRBs, and sponsors. WIRB can help you write your protocol or your consent form, and provide regulatory support for local IRBs.

WIRB offers researcher and staff training to optimize the submission and implementation of their academic-sponsored and industry-sponsored research. Training covers a broad range, from consent form development, to best clinical practices, to site operations and standard operating procedures. WIRB also leverages its internal staff education programs to provide training to other IRBs, offering courses such as IRB audits and board member training. Learn more about our Education and Consulting Services.

IRB document translations

Critical time can be saved during the enrollment process by working with WIRB's translation team. We offer translation of written materials in any language, with translators who are experienced with the special needs and vocabulary of research studies. For more information on WIRB's translation services, contact us.

Getting started

To prepare your submission, please review the relevant industry regulations, view WIRB's submission resources on the final tab of this page, or contact us with questions. When you are ready to submit, log on to WIRBNET at the top right of this page.

View WIRB's Compliance Statement, and learn more about WIRB's registration with OHRP/FDA, AAHRPP accreditation, and electronic signatures' compliance with 21 CFR Part 11.

Getting it done right, and getting it done quickly, requires the kind of experience and capacity that WIRB offers. Our staff is deeply committed to streamlining your review process, while ensuring that your study adheres to the highest standards for protecting human research participants and complying with regulations. Throughout your review, we strive for efficiency that balances speed and quality—critical to helping you achieve both your short-term and long-term goals.

WIRB's IRB services for institutions and investigators include:

IRB outsourcing

WIRB provides review services for more than 400 institutions and their affiliates (academic centers, hospitals, networks, and in-house biotech research), as well as individual investigators, nationally and internationally. Our long-standing institutional relationships give us deep knowledge of unique investigator requirements and established consent language for different institutions, enabling us to develop efficient processes for comprehensive, streamlined reviews. Our staff and representatives are there for you ready to answer questions and exchange information about research protocols, regulations, submission requirements, or whatever you need to help you successfully develop, submit, and track your protocol.

Outsource both your academic and industry-sponsored research reviews to WIRB if your institution becomes inundated with review requests. We can help accelerate review turnaround time, reduce costs incurred by review delays, and provide the expertise needed to review any protocol.

Central IRB

WIRB has served as a central IRB for individual investigators since our inception. Our relationships and review histories with investigators around the world provide us with more insight into human protection regulations and regulatory nuances than any other independent IRB.

Multi-center studies

With experience reviewing multi-center studies involving up to several thousand investigators—and representing institutions and investigators as a local, central, or multi-center IRB—WIRB has implemented time-saving and cost-saving review procedures and a dedicated account manager to accelerate the multi-center review process.

We work with sponsors and CROs to review up-front the initial protocol, changes in research, and associated documents, identifying issues to be addressed prior to formal submission. We also develop a consent form template for site use. And, to help rapidly onboard new sites, the Board meets three times weekly to review new sites joining a study that has already received Board approval.

A WIRB account manager is assigned to the protocol to facilitate research review and oversight, serving as a single point of contact for questions and communications, helping manage document flow, and coordinating communications between all investigators involved. Learn more about multi-center studies.

Clinical Pharmacology Unit review

WIRB provides streamlined reviews for dedicated clinical pharmacology units addressing healthy and diseased populations, including Phase 1, bioequivalence/bioavailability, diabetes, oncology, and renal disease research. We respond quickly to submissions, helping advance your research through local and international regulatory procedures anywhere in the world. Learn more about our CPU Services.

Global IRB services

With review experience in more than 70 countries, WIRB can help you meet all the logistical, cultural, and regulatory challenges of international research. If you are planning an international study, WIRB's established international network and deep knowledge of global regulations and cultural sensitivities can help pave the way for a compliant review around the globe. Learn more about our international and Canadian IRB services.

Education and consulting

WIRB's staff of experts and educators offers a wide array of education, consulting, and staffing services for investigators, local IRBs, and sponsors. WIRB can help you write your protocol or your consent form, and provide regulatory support for local IRBs. Learn more about our Education and Consulting Services.

IRB document translations

Critical time can be saved during the enrollment process by working with WIRB's translation team. We offer translation of written materials in any language, with translators who are experienced with the special needs and vocabulary of research studies. For more information on WIRB's translation services, contact us.

Getting started

To prepare your submission, please review the relevant industry regulations, view WIRB's submission resources on the final tab of this page, or contact us with questions. When you are ready to submit, log on to WIRBNET at the top right of this page.

View WIRB's Compliance Statement, and learn more about WIRB's registration with OHRP/FDA, AAHRPP accreditation, and electronic signatures' compliance with 21 CFR Part 11.

Overview

Special considerations

Investigator training

Getting Started

The following resources provide the regulations specific to your research. To see our full listing of submission forms required throughout the life of your research, create an account and/or log on to WIRBNET. On WIRBNET, you can access detailed information and submit your research for review with our convenient smart forms. Or, view and access our submission forms manually by clicking Download Forms next to WIRBNET Login at the top of the page.

Human research determination

It is the investigator's responsibility to determine whether the proposed clinical trial is in fact human subject research. The first step for any study is to determine whether it falls under the Human Subject Research legal designation. This determination is made by answering two cardinal questions:

a) Is it research? "Research is a systematic investigation designed to develop or contribute to generalizable knowledge." (45 Code of Federal Regulations Part 46)

b) Does it involve human subjects? "Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information." (45 CFR Part 46)

Please contact WIRB with any questions about the type of research you are conducting and the forms you will need to submit.

Investigators who conduct research at institutions need to be aware of any obligations they might have that require using the institution's IRB rather than WIRB.

As an independent IRB, WIRB is able to review where there is no requirement on an investigator to use a local IRB; or, in cases where there is a local IRB, the local IRB may opt to waive research oversight to WIRB or make arrangements to share oversight. In either case, the arrangement must be documented.

Some institutions have designated WIRB as an IRB for the institution. Institutional investigators should check with their local research office to determine what requirements, if any, must be fulfilled prior to submitting research to WIRB. Such issues as pre-review by internal committees, use of template consent form language, and approval/submission through a central office should be addressed with your local institutional officials.

Many of WIRB's institutional clients have designated WIRB as one of their IRBs or the sole IRB of record on their Federalwide Assurance (FWA). For more information, contact us.

How to file and amend an FWA

The federal Office for Human Research Protections (OHRP) requires that federally funded human subject research only be conducted at facilities covered by a Federalwide Assurance (FWA). Find out what an FWA is and when you need it.

For drug research, WIRB's initial review submission forms ask for information about an Investigational New Drug (IND) application. As a general rule, WIRB requires that a sponsor or investigator obtain an IND from FDA for clinical investigations involving drugs. Determine whether your drug research requires an IND.

Global reviews outside the U.S. and Canada

If you are planning an international study, WIRB can help pave the way for a compliant review around the globe. We reference local laws, customs, and attitudes to ensure that research is culturally and legally acceptable. We are able to act as the sole IRB in countries where regulations allow, or work with a local IRB or other review committee where it is required. Find out more about global reviews.

If you have additional questions regarding additional research considerations, please contact us.

Requirements for human subject protection training WIRB requires investigators to verify on the initial review submission form and each continuing review report form that each member of the research team has successfully completed training in human research subject protection. Your institution may have additional training requirements, so please check with your institutional official. Note that HIPAA training or prior research experience alone does not satisfy this requirement for training in human subject protection. WIRB's expectation is that your training includes topics such as ethical principles related to human subject protections, federal regulations for protection of human subjects, and good clinical practice.

Standard care therapy

When standard of care therapy is part of the research, WIRB only requires this training of staff members who are involved in the consent process, recording of data, submission of unanticipated problem reports, or other procedures specific to the research.

Training formats

WIRB accepts training completed in a variety of formats, such as online modules, live seminars, college courses, self- study texts that provide CEU or CME credit, and from a variety of sources—government entities, non-profit institutions, professional organizations, and commercial businesses.

Device research

Physicians and their teams who request approval for a Humanitarian Use Device (HUD) or treatment use of an investigational product are not required to complete human subject protection training.

Create an account and/or log on to WIRBNET to access more detailed information and submit your research for review, using our fast and convenient smart form submission technology. Or access our submission forms manually by clicking Download Forms next to WIRBNET Login at the top of the page.